A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of ALM16 on reducing body weight and body fat of overweight or obesity subjects
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004947
- Lead Sponsor
- Dong Il Pharmtec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
1) 20 years= Age = 60years
2) 25kg/m^2= BMI <32kg/m^2
3) Subject who voluntarily agree to participate and signs informed consent form
1) Subjects with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) within recent 6 months
2) Subjects for uncontrolled hypertension(systolicBP = 160 mmHg or diastolicBP = 100 mmHg)
3) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL
4) Subjects with TSH(thyroid-stimulating hormone) = 0.1 uIU/ml or = 15 uIU/ml
5) Subjects with Creatinine = 2 times the upper limit of normal
6) Subjects with AST or ALP = 3 times the upper limit of normal
7) Subjects with complaint of severe gastrointestinal symptoms such as heartburn, dyspepsia
8) Subjects who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, health functional food for diet, antidepressants, ß- blocker, diuretics, contraceptives, steroid, and female sex hormone) within recent 1 months
9) Participation in commercial diet program within the 3 months prior to screening
10) Participation in any clinical trial within the 1 month prior to screening or have a plan to participate in other clinical trial
11) Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system
12) Subjects with the musculoskeletal disorders or restricted physical activity
13) Women who are pregnant of lactating or planning to pregnant
14) Subjects which in the opinion investigator could affect preclude evaluation of response
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Whole body fat percentage by Dual Energy X-ray Absorptiometry
- Secondary Outcome Measures
Name Time Method Body weight;Brachial circumference, Femoral circumference, Waist circumference, Hip circumference, Waist-hip ratio(WHR);Body mass index(BMI);Mesenteric fat area, Subcutaneous fat area, Total abdominal fat area, Mesenteric fat area/Subcutaneous fat area(by CT);Basal metabolism rate;Blood Lipid;hs-CRP, Adiponectin, Leptin